BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 11336257 · Received February 16, 2021

    Report

    Report Number
    1911916-2021-00129
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 5, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0073383, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-03-13. MEDICAL DEVICE LOT #: 0115115, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: 2020-04-24 . (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 0073383. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PLASTIC SHIELD WITH DARK SPOTS. THE SPOTS LOOK LIKE EMBEDDED DEGRADED RESIN. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 NEEDLES FILTER BLUNT FILL 18X1-1/2 EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND BLACK PARTICLES ON THE INSIDE OF FILTER NEEDLES. THIS WAS OBSERVED BY PRODUCTION OPERATORS TOWARDS THE END OF CONSUMING BATCH 0073383. ITEM: 305211 . TODAY WE RECEIVED STOCK FROM BATCH 0115115, WHICH, FROM INSPECTION, ALSO HAS EXAMPLES WHERE THESE BLACK PARTICLES ARE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229382 NEEDLE FILTER BLUNT FILL 18X1-1/2 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 0115115

    Patients

    Seq Age Sex Outcome Treatment
    1